BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BONE CEMENT 2X40G

    MDR report key: 9314754 · Received November 13, 2019

    Report

    Report Number
    3006946279-2019-00460
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 21, 2019
    Report Date
    February 11, 2020
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    08428898344273
    PMA / PMN Number
    K150850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT (B)(4) PRODUCTS BIOMET BONE CEMENT R 40X2, REFERENCE 3035890022, BATCH A609AF1307 WERE MANUFACTURED ON (OCT 3RD, 2016). THE DEVICE MANUFACTURING QUALITY RECORD (OF 3894203) INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE COMPLAINT. 7 COMPLAINTS HAVE BEEN RECORDED OVER THE BATCH NUMBER A609AF1307 INCLUDED THE CURRENT COMPLAINT WITHIN ONE YEAR. ACCORDING TO AVAILABLE DATA, THE MOST PROBABLE ROOT CAUSE IS DUE TO PACKAGING ISSUE (SEALING PROCESS). CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS REPORTED ISSUE. ISSUE (COMPLAINT CATEGORY INNER CEMENT POUCH OPEN SEALING) EVENT DESCRIBED IN THE COMPLAINT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INNER PACKAGE WAS FOUND LEAKED. THIS ISSUE WAS DETECTED IN DISTRIBUTOR WAREHOUSE. THIS EVENT CONCERNS 4 PRODUCTS. NO ADVERSE EVENT HAS BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN REPORT SOURCE: (B)(6). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE REVIEW OF THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT 2042 PRODUCTS BIOMET BONE CEMENT R 40X2, REFERENCE 3035890022, BATCH A609AF1307 WERE MANUFACTURED ON (OCT 3RD, 2016). THE DEVICE MANUFACTURING QUALITY RECORD (OF 3894203) INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO NON CONFORMITY OR DEVIATION WAS OBSERVED WHICH COULD BE LINKED TO THE COMPLAINT ISSUE (COMPLAINT CATEGORY INNER CEMENT POUCH OPEN SEALING) EVENT DESCRIBED IN THE COMPLAINT. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INNER PACKAGE WAS FOUND LEAKED. THIS ISSUE WAS DETECTED IN DISTRIBUTOR WAREHOUSE. THIS EVENT CONCERNS 4 PRODUCTS. NO ADVERSE EVENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110717 BIOMET BONE CEMENT 2X40G BONE CEMENT LOD BIOMET FRANCE S.A.R.L. A609AF1307 08428898344273

    Patients

    Seq Age Sex Outcome Treatment
    1